SHIFT: First – 8:00am – 4:30pm some overtime may be required.
SUMMARY: Responsible for activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Review processes and procedures to support the activities in the Quality System.
1. Create, maintain and manage QS Database to provide support for the preparation, and maintenance of quality, manufacturing, testing, inspection, validation and product development related documents.
2. Ensure accuracy and integrity of records. Update files as needed and maintain accurate file history.
3. Responsible for initiating, routing, approving, releasing and analyzing change requests.
4. Manage, investigate and analyze customer field complaints, deviations, nonconformance’s, corrective and preventative actions.
5. Manage and audit training records.
6. Conduct training.
7. Create a variety of forms as needed to support regulatory compliance, quality and R&D functions.
8. Distribute routine reports and data, compile data and provide summary documentation for Annual Product Review.
9. Conduct batch record reviews and investigate discrepancies.
10. Participate and assist in audits.
11. Perform other related duties as required.
REPORTING RELATIONSHIP: This position reports to the Director of Quality and Regulatory
QUALIFICATIONS: Requires two year associates degree in science or math with at least two years of college level chemistry or a four year Bachelor of Science Degree. A minimum of 2 years work experience in quality control or assurance is highly desired. Knowledge of statistics and basic FDA GMP requirements. Skilled in written and oral communication and skill in establishing interpersonal relationships Basic knowledge and skills sufficient to manipulate and use Microsoft and other software including word processing, spreadsheets, email, internet and MRP systems. Certification in Six Sigma, Quality Auditor, Quality Inspector or Quality Process Analyst is desired but not a requirement.